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Trial registered on ANZCTR


Registration number
ACTRN12617000308392
Ethics application status
Approved
Date submitted
11/02/2017
Date registered
27/02/2017
Date last updated
24/07/2019
Date data sharing statement initially provided
24/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
An international study to develop a questionnaire module to measure quality of life in melanoma patients
Scientific title
International validation study of the EORTC QLQ-MEL-38, a new melanoma quality of life questionnaire
Secondary ID [1] 291124 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 301962 0
Quality of life 301963 0
Condition category
Condition code
Cancer 301615 301615 0 0
Malignant melanoma

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study aims to develop a questionnaire - the EORTC QLQ-MEL-38 - measuring the quality of life (QOL) for patients with melanoma. EORTC stands for the 'European Organisation for Research and Treatment of Cancer' and the melanoma questionnaire is being studied by the quality of life working group. The QLQ_C30 has been adapted for many specific cancer types. The objective of the study is to better understand and evaluate the experience of people diagnosed and treated for melanoma and its impact on their life.

Patients with melanoma will be asked to complete a data collection pack containing some questionnaires whilst they are waiting to be seen at an outpatient appointment. A member of the research team will complete a form by asking the patient some socio-demographic information including: age, gender, initials, date of birth, indigenous status, country of birth, level of education attained, living circumstances and employment status..The study team member will then ask about the treatment and investigations for melanoma the patient has had and how long they have been attending the clinic.

Patients are then asked to complete 2 standard questionnaires (EORTC QLQ-C30 and HADS), followed by a questionnaire that is the new research tool being tested. The EORTC QLQ-C30 questionnaire is a tool to asses the quality of life in patients with any form of cancer. It includes questions about the patient's rating of his/her physical and mental health. The Hospital Anxiety and Depression Scale (HADS).questionnaire is used to assess the levels of anxiety and depression that a patient may be experiencing.

After completing the questionnaires, patients are asked to complete a survey asking what they thought of the questionnaires and if they required help in answering them.

The entire process should take approximately 40 minutes. Patients may have any stage of melanoma which has been diagnosed in the past 5 years and they may be at any point in their treatment journey. Patients who complete the above data collection pack and who are in routine follow up care will be invited to re-take the same questionnaires a second time at 2 weeks from the first completion. This is to examine the reliability and validity of the melanoma questionnaire.
Intervention code [1] 297115 0
Not applicable
Comparator / control treatment
The new melanoma questionnaire will be compared with two standard and previously validated questionnaires: EORTC QLQ-C30 and HADS.
Control group
Active

Outcomes
Primary outcome [1] 301016 0
Sensitivity and specificity of EORTC QLQ-MEL-38 in comparison to QLQ-C30 and HADS for patients with melanoma who are at all stages of the disease and undergoing all phases of treatment or palliation.
Timepoint [1] 301016 0
The questionnaire is completed once by each patient who may be at different stages of their treatment pathway: (a) early after diagnosis of any stage of disease; (b) 14 days after surgery; (c) 3 months after surgery; (d) 1 month after starting systemic treatment and (e) 3 months after starting system treatment., The Recruitment to the study is expected to take one year.
Secondary outcome [1] 331462 0
Confirmation of the test-retest reliability of the questionnaire in patients with local disease (stage I and II) who are undergoing routine follow up after treatment for melanoma.
Timepoint [1] 331462 0
Two weeks after completing the first questionnaire
Secondary outcome [2] 331464 0
Correlation of the composite of disease stage and treatment phase in those patients with the highest and lowest quality of life questionnaire scores (representing the worse and best patient related quality of life).
Timepoint [2] 331464 0
At baseline and at two weeks later.
Secondary outcome [3] 331468 0
Identification of differences in EORTC QLQ-MEL-38 quality of life responses between patients at each end of the socio-demographic spectrum, as defined by the study-specific socio-demographic interview.
Timepoint [3] 331468 0
At baseline and at two weeks later.
Secondary outcome [4] 331470 0
Identification of any differences in quality of life responses between patients at local stage of disease versus metastatic disease
Timepoint [4] 331470 0
At baseline and at two weeks later.
Secondary outcome [5] 331557 0
Validity of the questionnaire structure by principal components analysis (PCA) with Oblimin rotation.
Timepoint [5] 331557 0
At baseline and at two weeks later.
Secondary outcome [6] 331562 0
Proximity in score of the new melanoma QoL with the longstanding and validated questionnaires: Hospital Anxiety and Depression Scale (HADS) and the EORTC QLQ-C30 (which the patient will also complete at the same time as the melanoma QoL).
Timepoint [6] 331562 0
At baseline and at two weeks later.
Secondary outcome [7] 331990 0
Identification of any differences in quality of life responses between male and female patients
Timepoint [7] 331990 0
At baseline and at two weeks later.
Secondary outcome [8] 331991 0
Identification of any differences in quality of life responses between patients currently undergoing treatment versus patients in follow up.
Timepoint [8] 331991 0
At baseline and at two weeks later.

Eligibility
Key inclusion criteria
1. Confirmed diagnosis of melanoma within the past 5 years
2. Aged 18 or over
3. Able to give written informed consent
4. Fluency in the language of the country where the study is being undertaken
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participating in any other quality of life study
2. A psychiatric condition or major cognitive impairment that would hamper the completion of a self-reported quality of life questionnaire

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
1. Standard statistical tests will be performed using SPSS, all hypothesis testing will be two-sided and considered significant if p<0.05. Data distributions (item responses) will be examined by descriptive statistics and item analysis performed to identify outliers and any items with restriction in range (e.g. floor or ceiling effects). For the QLQ-C30, missing values will be treated in accordance with existing guidelines. For items in the Melanoma Module, missing values analysis and estimation/imputation of missing values may be performed if less than 10% of data are missing.

2. Factor structure: Preliminary psychometric testing, conducted at the end of Phase 3 has already identified a set of hypothesised scales for the Melanoma Module. These Phase 4 data will be used to re-confirm whether the factor structure still holds via Principal Components Analysis (PCA) with Oblimin rotation. Items with a factor loading coefficient greater or equal to 0.4 will be retained in each subscale. Scores for items with negative loadings will be reversed and scales calculated in the normal way by simple addition of the scores for each item within each factor, as recommended by Gorsuch. Rasch analysis using RUMM 2030 will be carried out to assess consistency of item functioning across the sample.

3. Reliability: Item reliabilities will be examined using Cronbach Alpha coefficients with alpha = 0.70 considered to reflect an optimal internal consistency.

4. Face and Content Validity: This will be assessed by selecting subsets of patients, with lowest and highest scoring questionnaires and reviewing the clinical pathways and current outcomes for these patients.

5. Convergent and Discriminant Validity: Multi-trait scaling analysis will be employed to examine whether the individual items in the module can be aggregated into hypothesised multi-item scales. Evidence of item convergent validity is defined as correlation of 0.40 or greater between an item and its own scale (corrected for overlap). Means, standard deviations, medians and 95% confidence intervals around the median will be calculated using Confidence Interval Analysis. Test retest correlations will be calculated using an Intra Class Correlation developed by Shrout and Fleiss..

6. Construct validity: Each of the scales will be examined by performing a range of significance tests. Based on the findings from the literature review and interview data, various hypotheses will be generated and tested using individual scale and total scores. Using the demographic characteristics to form distinct groups from within the whole sample, non-parametric statistical methods will be used to identify and measure differences between extreme groups, as recommended by Siegel. Group comparisons will include local disease group versus metastatic groups, male versus female, current treatment group versus follow up group and change in ECOG status

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
22/04/2016
Date of last participant enrolment
Anticipated
30/06/2018
Actual
28/03/2019
Date of last data collection
Anticipated
28/07/2018
Actual
29/06/2019
Sample size
Target
360
Accrual to date
Final
89
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 7453 0
The Poche Centre, Melanoma Institute Australia - North Sydney
Recruitment hospital [2] 7454 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 15280 0
2060 - North Sydney
Recruitment postcode(s) [2] 15281 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 8642 0
United Kingdom
State/province [1] 8642 0
Oxfordshire
Country [2] 8643 0
United Kingdom
State/province [2] 8643 0
London
Country [3] 8644 0
United Kingdom
State/province [3] 8644 0
Lanarkshire
Country [4] 8645 0
Serbia and Montenegro
State/province [4] 8645 0
Belgrade
Country [5] 8646 0
Germany
State/province [5] 8646 0
Heidelberg

Funding & Sponsors
Funding source category [1] 295563 0
Charities/Societies/Foundations
Name [1] 295563 0
Friends of the Mater Foundation
Country [1] 295563 0
Australia
Funding source category [2] 295586 0
Charities/Societies/Foundations
Name [2] 295586 0
the European Organisation for Research and Treatment of Cancer (EORTC)
Country [2] 295586 0
Belgium
Funding source category [3] 295705 0
Charities/Societies/Foundations
Name [3] 295705 0
Melanoma Institute Australia
Country [3] 295705 0
Australia
Primary sponsor type
Other Collaborative groups
Name
European Organisation for Research and Treatment of Cancer (EORTC)
Address
Avenue Emmanuel Mounier 83/11
1200 Brussels
Country
Belgium
Secondary sponsor category [1] 294389 0
Charities/Societies/Foundations
Name [1] 294389 0
Melanoma Institute Australia
Address [1] 294389 0
40 Rocklands Road,
North Sydney, NSW 2065
Country [1] 294389 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296883 0
SLHD Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 296883 0
Ethics committee country [1] 296883 0
Australia
Date submitted for ethics approval [1] 296883 0
20/02/2015
Approval date [1] 296883 0
21/05/2015
Ethics approval number [1] 296883 0
X15-0055

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1453 1453 0 0
/AnzctrAttachments/372317-EORTC QLQ-M38_V1 30April2014.pdf (Supplementary information)

Contacts
Principal investigator
Name 72326 0
A/Prof Julie Winstanley
Address 72326 0
Melanoma Institute Australia
40 Rocklands Road
Wollstonecraft NSW 2065
Country 72326 0
Australia
Phone 72326 0
+61 2 9957 7744
Fax 72326 0
Email 72326 0
julie.winstanley@sydney.edu.au
Contact person for public queries
Name 72327 0
Teagan McGuigan
Address 72327 0
Melanoma Institute Australia
40 Rocklands Road
Wollstonecraft NSW 2065
Country 72327 0
Australia
Phone 72327 0
+61 2 9911 7384
Fax 72327 0
Email 72327 0
Teagan.McGuigan@melanoma.org.au
Contact person for scientific queries
Name 72328 0
Julie Winstanley
Address 72328 0
Melanoma Institute Australia
40 Rocklands Road
Wollstonecraft NSW 2065
Country 72328 0
Australia
Phone 72328 0
+61 2 9957 7744
Fax 72328 0
Email 72328 0
julie.winstanley@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not applicable to this study


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.